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Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Primary Purpose

Bronchiolitis Obliterans, Sleep Disordered Breathing Central

Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Assessment of sleep disorders and treatment if required
Sponsored by
The Prince Charles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bronchiolitis Obliterans focused on measuring Lung transplantation, Bronchiolitis obliterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 & 3
  • Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0
  • Identified possible sleep related disorder

Exclusion Criteria:

  • Subjects who do not provide informed consent
  • Subjects unable to understand the study and related procedures
  • Patients with a life expectancy of less than 6 months

Sites / Locations

  • The Prince Charles Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bronchiolitis Obliterans 2 & 3

Bronchiolitis Obliterans 0

Arm Description

Assessment of sleep disorders and treatment if required

Assessment of sleep disorders and treatment if required

Outcomes

Primary Outcome Measures

To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Using level one laboratory based polysomnograph

Secondary Outcome Measures

Quality of life assessment using Rand SF36 standard survey
Participants will complete Rand SF36 standard survey for Quality of life. This will be completed at baseline visit and at 6 and 12 months post sleep study

Full Information

First Posted
April 7, 2014
Last Updated
May 11, 2020
Sponsor
The Prince Charles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02109237
Brief Title
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3
Official Title
The Prevalence and Treatment of Sleep Disorders in Lung Transplant Recipients With BOS 2 & 3 and the Influence on Quality of Life and Daytime Activity.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Prince Charles Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.
Detailed Description
Patients with Bronchiolitis Obliterans syndrome (BOS) 2 & 3 (25) will be matched 1:2 BOS 0 patients with similar demographics such as age, gender, BMI, time post transplant and renal dysfunction.Patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (QOL), any sleep issues they may have and be assessed by a doctor. Data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. All participants will undergo an overnight sleep study. If a sleep disorder is identified the participant will be offered appropriate treatment. All assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans, Sleep Disordered Breathing Central
Keywords
Lung transplantation, Bronchiolitis obliterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchiolitis Obliterans 2 & 3
Arm Type
Experimental
Arm Description
Assessment of sleep disorders and treatment if required
Arm Title
Bronchiolitis Obliterans 0
Arm Type
Active Comparator
Arm Description
Assessment of sleep disorders and treatment if required
Intervention Type
Procedure
Intervention Name(s)
Assessment of sleep disorders and treatment if required
Other Intervention Name(s)
Level 1 polysomnograpgh assessment and treatment if required
Intervention Description
Assessment of sleep disorders and treatment if required
Primary Outcome Measure Information:
Title
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
Description
Using level one laboratory based polysomnograph
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life assessment using Rand SF36 standard survey
Description
Participants will complete Rand SF36 standard survey for Quality of life. This will be completed at baseline visit and at 6 and 12 months post sleep study
Time Frame
Baseline, 6 and 12 months after sleep study
Other Pre-specified Outcome Measures:
Title
Assessment of daytime activity, mobility and muscle strength
Description
As part of standard care transplant patients are assessed for daytime activity, mobility and muscle strength every 6months this data will be used to assess any changes post treatment for sleep disorders
Time Frame
Baseline, 6 and 12 months post sleep study
Title
Lung function assessment
Description
Assessment of lung function to determine any variation post treatment for sleep disorder.
Time Frame
Baseline, 6 and 12 months post sleep study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 & 3 Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0 Identified possible sleep related disorder Exclusion Criteria: Subjects who do not provide informed consent Subjects unable to understand the study and related procedures Patients with a life expectancy of less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Fiene, BA Med,Surg. FRACP MD
Organizational Affiliation
The Prince Charles Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Douglas, MBBS FRACP MD
Organizational Affiliation
The Prince Charles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

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